In the manufacture and utilization of business forms for a wide variety of medical containers it is necessary to use some sort of tamper evident feature. Particularly in association with business forms that are used in drug testing or other specimen collection where the integrity of the specimen collected, or integrity of other contents of a container, is necessary, a wide variety of tamper evident techniques are utilized. Some exemplary techniques for this purpose are seen in U.S. Pat. Nos. 4,873,193, 5,411,295, and 5,495,944. The most common commercial systems utilize a tamper evident label having a length such that it engages one side wall, the removable cap, and the opposite side wall of a medical container (such as a specimen vial, bottle, or the like). The label stock used is typically a paper base face stock with an aggressive adhesive, such as available from Fasson. While these labels can be very worthwhile, under some conditions a very careful person intent on tampering might be able to remove the label from one side of the container without tearing the label by pulling the adhesive away from the side wall of the container.
When providing business forms for medical purposes, it is desirable to provide a number of different labels which can provide a variety of different functions, with the same form. For example one or more labels may be provided to allow one or more specimen vials to be sealed in a tamper evident manner, while at the same time a label is provided to seal a box in which the vial may be transported. Other labels may facilitate tamper evident functions by being placed on other portions of the vial to be sealed, or to provide bar coding or other indicia useful for some purpose associated with the provision of the labels.
According to the invention a business form is provided that is ideally suited for use in recording information about, and appropriately labeling, medical containers, such as drug testing specimen vials, and associated procedures, dispensing of pharmaceutical substances, or the like. The business forms according to the present invention are highly convenient, versatile, and effective in providing a variety of functions.
The invention also relates to a particular label configuration, and a combination of label with medical container, that are advantageous compared to the art. According to the invention a full wrap label is provided for a container which has enhanced tamper evident functionality because the label material is brought into actual contact with label material, making it more difficult to tamper with the container without being noticed.
According to one aspect of the present invention a business form is provided comprising the following components: A first, multiple ply, paper form portion having form entry indicia thereon, parallel top and bottom edges, and first and second side edges perpendicular to the top and bottom edges. Image transfer means associated with the multiple plies to transfer indicia impact imaged on one ply to at least one other ply. A second release liner form portion attached to one edge of at least one ply of the first form portion. At least three distinct labels disposed on the second form portion, each label having top and bottom surfaces, pressure sensitive adhesive on the bottom surface thereof, which adhesive engages the release liner second form portion, and indicia on the top surface thereof. A first of the distinct labels being dimensioned and configured to hold a removable cap on a medical container to indicate if the container cap has been tampered with, and wherein the pressure sensitive adhesive on the bottom surface thereof is permanent adhesive. And, a second of the distinct labels being dimensioned and configured to seal a box for containing a medical container, and having indicia on the top surface thereof indicating use of the label for sealing a box, and wherein the pressure sensitive adhesive on the bottom surface thereof is permanent adhesive.
The indicia on the top surface of the first label may comprise substantially centrally located indicia indicating that the indicia is to be placed on the removable cap of a medical container, such as a specimen vial, pharmaceutical substance containing bottle, or the like. A machine readable indicia on and common to at least the first and second labels may also be provided. There may also be a third distinct label substantially the same as the first label, although perhaps of a different length.
The business form may also have a second ply of paper connected to and underlying the second business form portion, with image transfer means associated with the second ply to transfer indicia impact imaged on at least one of the labels on the release liner to the second ply. This image transfer means--as well as the image transfer means associated with the multiple plies of the first portion of the form--may comprise conventional self-contained coatings, or cooperating CF/CB coatings, carbon paper, or any other conventional mechanism for relatively easily and inexpensively transferring an image from one ply to another.
The second business form portion may be connected to the second side edge of the first business form portion substantially along the entire length thereof. Tractor drive holes may be provided in the first and second portions along the first side edge of the first portion, and along an edge of the second portion most remote from and parallel to the first side edge of the first portion.
The first label may have a length sufficient to wrap completely around the removable cap and the bottom of a medical container so that one portion of the first label is affixed to another portion of the first label when the substantially centrally located indicia is over the removable cap of the medical container. For example when designed to be used with a 90 ml plastic (e.g. polypropylene) conventional specimen vial, the first label may have a length of between about 10-11 inches, typically about 10.5 inches, and a width of less than two inches, typically about 7/8 inch. The first label may have serrated side edges, as is known per se for specimen labels, and serrated end edges. Also conventional interlocking circle tamper evident features may be provided to facilitate the irremovability of the first label, and such features may also be provided in the box seal for the same purpose. Interlocking die cut circles are known in tamper evident labels per se, and they may be of conventional construction.
According to another aspect of the present invention a business form is provided comprising the following components: A first, multiple ply, paper form portion having form entry indicia thereon, parallel top and bottom edges, and first and second side edges perpendicular to the top and bottom edges. Image transfer means associated with the multiple plies to transfer indicia impact imaged on one ply to at least one other ply. A second release liner form portion attached to one edge of at least one ply of the first form portion. At least two distinct labels disposed on the second form portion, each label having top and bottom surfaces, pressure sensitive adhesive on the bottom surface thereof, which adhesive engages the release liner second form portion, and indicia on the top surface thereof. A first of the distinct labels being dimensioned and configured to hold a removable cap on a medical container to indicate if the container cap has been tampered with, and wherein the pressure sensitive adhesive on the bottom surface thereof is permanent adhesive. And, wherein the indicia on the top surface of the first label comprises substantially centrally located indicia indicating that the indicia is to be placed on the removable cap of a medical container. The details of the various components of the form, particularly the first label, may be as described above.
The invention also relates to a container assembly per se. The container assembly according to the invention comprises the following components: A medical container having a plastic or glass body with closed sides and a closed bottom and an open top, and a removable cap closing the open top. A first label having a top surface with indicia thereon and a bottom surface with permanent pressure sensitive adhesive thereon. And, the label wrapped completely around the medical container contacting the removable cap, at least a portion of the sides, and the bottom thereof, and the pressure sensitive adhesive of a portion of the first label engaging the top surface of another portion of the first label.
The first label used in the container assembly may be the label specifically as described above in association with a business form according to the invention. Wherein the container is a 90 ml plastic specimen vial, or the equivalent, the first label typically has a length of between about 10-11 inches, e.g. about 10.5 inches, and a width of less than two inches, e.g. about 7/8 inch. The invention is also useful with other conventional medical containers, such as 60 ml plastic specimen containers, pharmaceutical substance (e.g. pill) containing bottles, or the like, and the label will be dimensioned and configured so as to be appropriately useful with a given container and having the enhanced tamper evident functionality provided according to the invention.
The container assembly may also comprise at least a second label, having a length much shorter than the first label (e.g. only about 2-5 inches) and permanent pressure sensitive adhesive, the second label adhesive engaging the cap and a side of the medical container.
The invention also relates to a label per se for which in providing tamper evident sealing of a medical container. The label may be lined--that is having a release liner associated therewith--or linerless--that is with a release coat on the top face thereof (which containers the indicia) and wrapped up in a spiral configuration, or provided in a roll. The label may be in a kit as the only component of the kit or one of several components of the kit, for performing any particular desired function, such as maintaining the integrity of specimens collected for drug testing. The label typically comprises: A paper or plastic substrate having a top surface and a bottom surface, first and second serrated side edges having a length of between about 10-11 inches, and end edges having a length of less than two inches. Substantially centrally located indicia on the top surface indicating that the indicia is to be placed on a removable cap of a medical container. And, permanent pressure sensitive adhesive on the bottom surface.
The invention also relates to a method of using the label as described above with a medical container having an open top covered by a removable cap, and a closed bottom and sides. The method comprises the steps of: (a) placing the adhesive of the label on the removable cap so that the substantially centrally located indicia overlies the cap; (b) wrapping the label around the container so that some of the pressure sensitive adhesive engages the sides and bottom of the container; and (c) bringing a portion of the label pressure sensitive adhesive into contact with the top surface of another portion of the label at or adjacent the container bottom.
It is the primary object of the present invention to provide an advantageous business form, container assembly, label for use in providing tamper evident sealing of the medical container, and a method of use of such a label. This and other objects of the invention will become clear from an inspection of the detailed description of the invention and from the appended claims.